Events

Alerte De Sécurité sur 1 Day Acuvue TruEye

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Johnson & Johnson.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2010-10-27
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20101028.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Further recall of single-use contact lenses further to the voluntary recall of contact lens "1 day acuvue trueye" announced on august 19, the department of health (dh) was notified by johnson & johnson (hk) limited today (october 27) that the company is extending the recall lots of the product. a dh spokesman said the affected batch was manufactured in ireland with lot numbers falling between 492237 and 492498 and between 502080 and 502269, which include the 16 batches of product announced on august 19. these numbers are the first six digits of the lot number printed at the side of the product box. according to johnson & johnson, detailed investigation into the incident in august revealed that the lens rinsing process on two production lines did not meet the internal production standards of the company, leading to a residual trace amount of diluent in the lenses. in hong kong, there has so far been no reported adverse event arising from use of the affected lots. according to the local supplier, 11 800 boxes in additional to the 3715 boxes of the affected lots announced on 19 august are affected in hong kong. the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2512 2112, for recall and product replacement. the hotline will operate from today onwards between 9am and 6pm from monday to friday. the recall details can also be accessed at the website, www.Acuvue.Com.Hk. those who feel unwell after using the product should seek advice from their healthcare professionals. meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue. the recall will be closely monitored. ends/wednesday, october 27, 2010.

Device

1 Day Acuvue TruEye
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Contact lens problems
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson